COVID-19 therapies development, review processes geared to accelerate.

Bio/Pharma Works OT on COVID-19 Therapies

Overcoming capacity, supply chain, and technology hurdles.

Scaling Up Vaccine Manufacturing

Filling vaccine vials and syringes must be fast and GMP-compliant.

Need for Fill/Finish Inspection Speed

Topic

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Articles

Since FDA authorization of two innovative mRNA vaccines to combat COVID-19 in late 2020, 30 million doses have been distributed, but only 4 million people were vaccinated in December 2020, and just 13 million have received shots so far. 

Vaccine Rollout Even Worse than Expected

The CPhI event, which was originally scheduled for Aug. 31–Sept. 2, 2021 at the Fiera Milano in Milan, Italy, will be rescheduled for Nov. 9–11, 2021 at the same venue.

CPhI Worldwide Moves to November 2021

This new agreement covers 1.25 million additional doses of the antibody cocktail containing casirivimab and imdevimab for the treatment of COVID-19.

US Government to Purchase Additional Doses of Regeneron’s COVID-19 Antibody Cocktail

A report on the FDA PREPP initiative’s work in 2020 aims to strengthen the Agency’s response to future public health emergencies. 

FDA Publishes COVID-19 Pandemic Recovery and Preparedness Plan Summary Report 

Baxter will provide commercial-scale manufacturing services at its Halle/Westfalen, Germany facility to prepare Novavax’s COVID-19 vaccine candidate for distribution in the United Kingdom and European markets.

Baxter and Novavax Enter into COVID-19 Vaccine Sterile Manufacturing Agreement

The company plans to expand its global production capacity across six existing manufacturing facilities in Europe and the United States, as well as a new manufacturing facility in the US.

Pall to Invest $114 Million to Expand its Global Production Capacity

Bayer will support the development and supply of CureVac’s COVID-19 vaccine candidate, CVnCoV.

Bayer and CureVac to Collaborate on COVID-19 Vaccine Candidate

The company plans to deliver initial doses by mid-2021, and Australia will have the option to purchase up to 10 million additional doses through the agreement. 

Novavax Enters into Agreement with the Commonwealth of Australia for 51 Million Doses of its COVID-19 Vaccine

The European Commission has granted a conditional marketing authorization to Moderna for its COVID-19 vaccine.

EC Authorizes Moderna’s COVID-19 Vaccine for European Roll-Out

Mike Hennessy, Sr., is the founder and chairman of MJH Life Sciences.

Viewpoint: Mike Hennessy, Sr., founder and chairman of MJH Life Sciences, recognizes efforts of the pharmaceutical industry in combatting the COVID-19 pandemic.

How Pharmaceutical Innovation is Saving the World

Amid pressure to get more vaccines administered faster, FDA pushes back against changes in dosing regimens.

FDA: Stick with Approved EUAs for COVID-19 Vaccines

Part of Operation Warp Speed, the trial will enroll 30,000 people ages 18 to 64 and 65 and older at 115 sites.

Phase III Trial of Novavax COVID-19 Trial Open for Enrollment in the US and Mexico

The companies have entered into an agreement to support the formulation and fill/finish of Moderna’s COVID-19 vaccine supply outside of the United States. 

Moderna and Recipharm Announce COVID-19 Vaccine Supply Agreement 

After a hectic 2020, biopharma looks to deliver on COVID-19 vaccines and move other promising therapies forward.

Biopharma Gets Back to “New Normal” Business

Shutting down the COVID-19 pandemic requires a global, selfless effort.

Ensuring Vaccine Supply Meets Need

Administration of the COVID-19 vaccination from Oxford University and AstraZeneca is expected to begin in the UK in early 2021.

Oxford/AstraZeneca Vaccine Granted Emergency Use Approval in UK

President Trump signed the COVID-19 package, which appropriates $2.3 trillion to finance the federal government through September 2021 and provides support for individuals and entities suffering from the economic crisis wrought by the pandemic. 

Pandemic Relief Legislation Provides Economic Assistance, Boosts Federal Budgets

The agency is organizing a second public meeting on January 8, 2021 to discuss the assessment, approval, and roll-out of new COVID-19 vaccines.

EMA to Hold its Second Public Meeting on COVID-19 Vaccines

Moderna’s mRNA vaccine to prevent COVID-19 disease is granted FDA Emergency Use Authorization and CDC recommendation. 

Second COVID-19 Vaccine Granted EUA, Ships for Immediate Use

A decision by the European Commission on conditional marketing authorization for the European Union’s first COVID-19 vaccine is expected soon.

COVID-19 Update

Bio/Pharma Works OT on COVID-19 Therapies

Scaling Up Vaccine Manufacturing

Need for Fill/Finish Inspection Speed